Clinical equipoise

Clinical equipoise, also known as the principle of equipoise, provides the ethical basis for medical research involving patients assigned to different treatment arms of a clinical trial. The term was first used by Benjamin Freedman in 1987.

Ethical concerns during a clinical trial arise in human trials when the investigator(s) begin to believe that one arm of the trial is more beneficial than another. Even if the researcher truly believes in a hypothesis, there is no actual proof that the benefit exists. Once there is sufficient evidence, the research is usually stopped since clinical equipoise is not met.

Clinical equipoise means that there is genuine uncertainty over whether a treatment will be beneficial. This applies also for off-label treatments performed before or during their required clinical trials.

History

Shaw and Chalmers had argued that "If the physician knows, or has good reason to believe that a new therapy (A) is better than the other treatments (B), can not participate in a comparative study of the therapy versus Treatment B. Ethics the clinician is obliged to give any new therapy requires a patient such therapies. "[2] He also stated that no results should be suspended pending the completion of the researchers during the trial to avoid the ethical dilemma of researchers, and allows the entire study .

This method proves to be difficult for modern research, where many clinical studies to be carried out and analyzed by experts in that field. Freedman proposed a different approach to this so-called ethical dilemmas in clinical balance. Clinical balance is satisfied "if there is real uncertainty in the expert medical community - not necessarily a part of each test - the preferred treatment." [1] allows a balance to the clinical trial was to continue the trial until there is enough statistical evidence to convince other experts on the validity of their results, without loss of ethical integrity of the investigators.

Balance is also an important aspect of planning a study of the patient's point of view. This is particularly true in the randomized controlled trials of surgical interventions, where both the trial and the control arm, probably due to its risks and expected benefits. The condition of the patient is also a factor in these risks. Offering a balance of patients is an important part of patient recruitment in this regard, studies in which the balance was not likely suffered from poor shooting in the past., (2004), 91, 6-16</ref>

External links

• For and against, BMJ 2000;321:756-758